Wied, Schrier Introduce Bipartisan BLOOD Centers Act

WASHINGTON — Congressman Tony Wied (R-WI) and Congresswoman Kim Schrier (D-WA) introduced bipartisan legislation to help improve the quantity of our nation’s blood supply and streamline the opening of new blood centers.

“At a time when our nation’s blood supply has reached a critical low, we must do everything we can to cut through red tape to ensure that people who are willing to donate can do so easily and swiftly,” said Congressman Wied. “That is why I am proud to introduce the bipartisan BLOOD Centers Act to expedite the ability of blood centers to open new locations and collect life-saving blood for those who need it.”

The Boosting Lifesaving Operations, Opening Donation (BLOOD) Centers Act would require the FDA to establish an expedited supplemental Biologics License Application (BLA) process for blood centers with three existing BLA licenses or one or more BLA licensed location with an additional industry accreditation that exceeds FDA standards. Additionally, it requires the FDA to approve the supplemental BLA application within 30 days unless a blood center has shown a systemic failure to meet standards ensuring “safety, purity, and potency” of their blood products or specific concerns about the location of the supplemental application.

"As a doctor, I know that donated blood products save lives in dire situations," said Congresswoman Schrier, M.D. “Redundant regulation and red tape make it harder for blood centers to get blood products where they are needed, when they are needed.  I'm proud to join my colleagues in introducing this bipartisan legislation to reduce unnecessary administrative hurdles without compromising patient safety." 

Background: In recent years, we have seen blood centers, such as the Red Cross, warn of low blood supplies and urge more people to donate. Blood centers have reported an increase in donors choosing to donate at physical locations rather than mobile options, but over regulation from the FDA hinders blood centers’ ability to add new physical locations. When collecting blood in a physical location by apheresis, a common method of blood collection, the FDA requires the addition of a new fixed site to their approved biologics license applications (BLA) in order to ship blood products interstate. This licensing process, which is not needed for mobile blood donation, can take over a year despite blood centers often using the same standard operating procedures, staff, and machines across their locations. This significantly hinders blood centers’ ability to adjust to meet the demand from patients.

Congressman Wied and Congresswoman Schrier are proud to have the support of America’s Blood Centers.

“America’s Blood Centers applauds Rep. Wied and Rep. Schrier for introducing legislation to modernize regulations that impede patient access to life-saving blood products. Current licensure requirements impose redundant FDA reviews every time a new collection site opens, even when the same equipment, staff, and procedures are already approved and in use. By streamlining this process, this legislation will eliminate inefficiencies, help new donation sites open in a timely manner, and ensure patients have access to the safe and available blood supply they depend on,” said Kate Fry, CEO of America’s Blood Centers.

Congressman Tom Tiffany (R-WI) is an original cosponsor of this legislation.

“Government red tape and delays can cost lives when every drop counts. The BLOOD Centers Act streamlines approvals and requires the FDA to act within 30 days so lifesaving donations can reach patients quicker,” said Congressman Tiffany.

Read the bill HERE.